MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 6; CEMENTLESS HIP STEM

Catalog Number	01.39.206
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	02/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 march 2018; lot 165320: (b)(4) items manufactured and released on 12 october 2016.Expiration date: 2021-10-03.No anomalies found related to the problem.To date, (b)(4)items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in due to pain 1 month after primary.The x-ray showed that the femoral bone was fractured spirally from proximal side to distal side of the femoral stem.The surgeon replaced with competitors long cement stem and the femoral bone was fixed with a wire.Acetabular cup was not replaced.The patient did not fall down and did not have the experience of any trauma.

• Brand Name: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 6
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7357665
• Report Number: 3005180920-2018-00164
• Device Sequence Number: 16579585
• Product Code: LZO
• UDI-Device Identifier: 07630030885662
• UDI-Public: 07630030885662
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/03/2021
• Device Catalogue Number: 01.39.206
• Device Lot Number: 165320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention